FDA.reportPublic FDA data

NDC 51672-5263-01 - Topicort

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-5263
Requested NDC
51672-5263-01
Package NDCs from labels
51672-5263-5, 51672-5263-1, 51672-5263-2, 51672-5263-3, 51672-5263-7, 51672-5263-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2026-03-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Topicort ® (Desoximetasone Ointment USP) 0.05%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2026-03-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-5263-1Topicort1 in 1 CARTONOINTMENT111
51672-5263-1Topicort15 g in 1 TUBEOINTMENT1511
51672-5263-2Topicort1 in 1 CARTONOINTMENT111
51672-5263-2Topicort30 g in 1 TUBEOINTMENT3011
51672-5263-3Topicort1 in 1 CARTONOINTMENT111
51672-5263-3Topicort60 g in 1 TUBEOINTMENT6011
51672-5263-5Topicort5 g in 1 TUBEOINTMENT511
51672-5263-5Topicort10 in 1 CARTONOINTMENT1011
51672-5263-7Topicort100 g in 1 TUBEOINTMENT10011
51672-5263-7Topicort1 in 1 CARTONOINTMENT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5263TOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]9Current NDC, Legacy NDC, 10 package rows20241222_96dfac6f-540f-4b7d-bcee-7e62088ebc93.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5263-1GM - Gram51672-526306effd42-563e-4fab-a370-fa1482018d9612012-07-24
51672-5263-3GM - Gram51672-5263426dbc17-a78e-45d8-a8b7-fe8ee1cd646d12012-07-24
51672-5263-7GM - Gram51672-5263634035fc-db06-4358-86b0-1a858182151612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesoximetasoneACTIVE INGREDIENT4E07GXB7AUTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]7
DesoximetasoneACTIVE MOIETY4E07GXB7AUTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]7
mineral oilINACTIVE INGREDIENTT5L8T28FGPTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]7
petrolatumINACTIVE INGREDIENT4T6H12BN9UTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]7

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 31 · 605 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vaseline Intensive Care Deep MoisturePETROLEUMConopco Inc. d/b/a Unilever65cec560-25c7-4076-a33d-a3dd534ff85b2026-03-16WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Vanilla Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jack71bb5177-20af-4aee-ab02-6687c51fe0a12026-03-14WarningsExact identifier
unii: 4T6H12BN9U
TopicortDESOXIMETASONESun Pharmaceutical Industries, Inc.96dfac6f-540f-4b7d-bcee-7e62088ebc932026-03-12Warnings, Adverse reactionsExact identifier
application number: NDA018594
ndc (package): 51672-5263-7
ndc (package): 51672-5263-3
ndc (package): 51672-5263-5
ndc (package): 51672-5263-2
ndc (package): 51672-5263-1
ndc (product): 51672-5263
ndc11 (package): 51672526301
rxcui: 1050394
rxcui: 141850
spl id: 4cd6638c-db25-e28b-e063-6294a90a4a9a
spl set id: 96dfac6f-540f-4b7d-bcee-7e62088ebc93
unii: 4E07GXB7AU
Panama Jack SPF 45 Mango Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jackbd0f6577-9638-4319-b759-348f357ce3972026-03-11WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Dreamsicle Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jack34e89add-ca63-4b66-bdf5-d47403c917702026-03-11WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Tropical Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jacka271ec3c-e0ea-4100-9a56-b127bbfef3472026-03-11WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A DWHITE PETROLATUMSion Biotext Medical Ltd.503c4ab9-1f60-48e2-af47-7ef996466a5b2026-03-09WarningsExact identifier
unii: 4T6H12BN9U
Pure petroleumWHITE PETROLATUMOld East Main Co.ae8583c0-1b52-461d-8506-ec7524f1b4c42026-03-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Healing for BabiesPETROLATUMOld East Main Co.aa1acc24-56af-4708-bf76-23d4de3d089e2026-03-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMOld East Main Co.de8d8071-ecb2-4719-8c7b-7944f27810d62026-03-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMOld East Main Co.cf916191-1de2-4305-b783-9e074c1ad94b2026-03-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Mineral OilMINERAL OILChain Drug Marketing Association3bfdad9c-ac58-4e92-b952-555e8a8351cd2026-02-27Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
PetroleumWHITE PETROLATUMThe Kroger Co.d2095c7b-61ca-40d3-bbf1-04bed4dd789c2026-02-27Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Vitamin A DLANOLIN, PETROLATUMWalmart Inc.5893801a-25e1-4750-a55b-d9cddd3f12842026-02-27Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Skin ProtectantPETROLATUMWalmart Inc.eb836922-f467-42ab-a6e7-b787d97e6c172026-02-27Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMWalmart Inc.aa7dbf7f-50be-475b-8140-68be3fa935072026-02-27Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
White PetrolatumWHITE PETROLATUMWalmart Inc.176d7711-7c4f-4319-91af-0aba1260c4122026-02-27Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Flavorless Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jack1b15c00b-0e78-4dbe-877c-de3941ffe76e2026-02-26WarningsExact identifier
unii: 4T6H12BN9U
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: 4T6H12BN9U
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4babe2ab-c5da-9a83-e063-6294a90aee4c2026-02-25WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.